HealthyPhase 4NCT00462111
Indomethacin and Mechanisms Underlying Risk of Falling
A Phase 4 study testing Indometacin in people with Healthy, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Indometacin
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 50-70 years old
- Not using any non-steroidal anti-inflammatory drugs (NSAIDs) for at least 3 days prior to the test session
Who cannot join
- Neurological or orthopedic disorders
- Poor comprehension of Dutch language
- Hearing problems
- Severe problems with heart and/or blood vessels
- Acutely existing ulcus ventriculi and/or duodeni, or history of ulcus
- Allergy against indomethacin, aspirin, or other NSAIDs
Show all 10Show fewer
- Patients with nasal polyps reacting with an angioedema to other NSAIDs
- Severe preexisting renal and liver damage
- Co-medication
- Over 100 kg of weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Indomethacin on Reaction Time, Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals.
The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles.
Read the detailed description
A lot of (epidemiologic) research is done on causes for falls and factors contributing to falling. Most of this research was conducted on the elderly, either community-dwelling or institutionalised. It became clear that the elderly have a greater risk at falling because of:
- physiological changes due to increasing age [Gerdhem et al., 2005]
- previous falls [Myers et al., 1991; Lipsitz et al., 1992]
- comorbidity (including RA) [Bergland et al., 2004; Gerdhem et al., 2005; Lawlor et al., 2003]
- polypharmacy [Lawlor et al., 2003; Walker et al., 2005; Ziere et al., 2005] and/or
- use of specific drugs like antidepressives, benzodiazepines, vasodilators, and NSAIDs [Cumming R, 1998; Herings RMC, 2001; Kallin K et al., 2004; Granek et al., 1987].
The relation between benzodiazepines and falling has been extensively investigated in and affirmed by several fields of research and is practically common sense. However, the (possible) relation between NSAIDs and falling is much less investigated, even though there are various articles in which a higher risk of falling when using NSAIDs is stated; sometimes the risk is even as high as with benzodiazepines [Cumming R, 1998; Granek et al., 1987; Walker et al., 2005].
Objective of the study:
NSAIDs are drugs that are often prescribed to patients with rheumatic or orthopedic diseases. They seem to be at a greater risk for falls than healthy persons because of their disease, age and medication use. Therefore it is very important to keep this risk as small as possible. In this study healthy adults are measured on reaction time, postural balance and obstacle avoidance with and without use of indometacin or placebo. This is done in order to gain more comprehension in the mechanism and actual risk for falls when using NSAIDs.
- Conditions
- Healthy
- Being tested
- Indometacin
- Keywords
- indometacin, reaction time, postural balance, obstacle avoidance, accidental falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndometacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate on the obstacle avoidance task
Secondary outcomes (2)
Reaction time
Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Investigators
- Jacques van Limbeek, MD, Principal investigator, Sint MaartenskliniekJaak Duysens, Prof, Study chair, St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462111
- Sponsor's protocol ID
- SKM002
- Status last verified
- Feb 2012
- First submitted
- 16 Apr 2007
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Indomethacin on Reaction Time, Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals.
- ClinicalTrials.gov ID
- NCT00462111
- Acronym / sponsor ID
- SKM002
- Conditions
- Healthy
- Keywords
- indometacin, reaction time, postural balance, obstacle avoidance, accidental falls
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles.
Detailed description
A lot of (epidemiologic) research is done on causes for falls and factors contributing to falling. Most of this research was conducted on the elderly, either community-dwelling or institutionalised. It became clear that the elderly have a greater risk at falling because of:
- physiological changes due to increasing age [Gerdhem et al., 2005]
- previous falls [Myers et al., 1991; Lipsitz et al., 1992]
- comorbidity (including RA) [Bergland et al., 2004; Gerdhem et al., 2005; Lawlor et al., 2003]
- polypharmacy [Lawlor et al., 2003; Walker et al., 2005; Ziere et al., 2005] and/or
- use of specific drugs like antidepressives, benzodiazepines, vasodilators, and NSAIDs [Cumming R, 1998; Herings RMC, 2001; Kallin K et al., 2004; Granek et al., 1987].
The relation between benzodiazepines and falling has been extensively investigated in and affirmed by several fields of research and is practically common sense. However, the (possible) relation between NSAIDs and falling is much less investigated, even though there are various articles in which a higher risk of falling when using NSAIDs is stated; sometimes the risk is even as high as with benzodiazepines [Cumming R, 1998; Granek et al., 1987; Walker et al., 2005].
Objective of the study:
NSAIDs are drugs that are often prescribed to patients with rheumatic or orthopedic diseases. They seem to be at a greater risk for falls than healthy persons because of their disease, age and medication use. Therefore it is very important to keep this risk as small as possible. In this study healthy adults are measured on reaction time, postural balance and obstacle avoidance with and without use of indometacin or placebo. This is done in order to gain more comprehension in the mechanism and actual risk for falls when using NSAIDs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 50-70 years old
- Not using any non-steroidal anti-inflammatory drugs (NSAIDs) for at least 3 days prior to the test session
Key exclusion criteria (10 listed)
- Neurological or orthopedic disorders
- Poor comprehension of Dutch language
- Hearing problems
- Severe problems with heart and/or blood vessels
- Acutely existing ulcus ventriculi and/or duodeni, or history of ulcus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indometacin | Drug | – |
Primary outcome
Success rate on the obstacle avoidance task
2 secondary outcomes
Reaction time
Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques van Limbeek, MD principal investigator
Sint Maartenskliniek
Jaak Duysens, Prof study chair
St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indometacin in people with Healthy, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate on the obstacle avoidance task. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.